MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA22-70/I16-30
Medical Device Problem Codes	Complete Blockage (1094); Patient-Device Incompatibility (2682); Appropriate Device Problem Term/Code Not Available (3191); Separation Problem (4043)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Obstruction/Occlusion (2422)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices were explanted and not returned; therefore, it will not be evaluated.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx with duraply.Devices were not returned.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 6 years post initial procedure patient was identified with a rapidly enlarged aneurysm and an impending rupture due to a type iiia endoleak.The physician elected to explant the devices which were disposed of after the procedure.The patient's current condition is unknown.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it was explanted and discarded by the hospital.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the type iiia endoleak of the aortic components with sac growth of 30.4mm are confirmed.The surgical conversion is unconfirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a left common iliac artery occlusion occurred that was not included in the event as reported.The left common iliac artery occlusion was seen on the 2021 computerized tomography (ct) scan and was unchanged and untreated on the 2022 ct scan.Additionally, it was determined that the type iiia endoleak included complete component separation.The most likely causation for the type iiia endoleak is the increased aortic angulation (aortic remodeling).It is unclear what caused the occlusion of the left common iliac artery.There was a 95mm long proximal extension and a 70mm long bifurcated stent implanted.There was only 10mm from the anatomic bifurcation to the inferior stent margin of the proximal extension.It is unclear if this contributed to the adverse event/incident.Procedure related harms for this complaint could not be determined.The final patient status remains unknown.The final patient status was not made available to endologix.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Device iteration is afx with duraply.B5: describe event or problem - updated.G3: awareness date ¿ updated.H6: medical device problem codes ¿ remove code 3191.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 6 years post initial procedure patient was identified with a rapidly enlarged aneurysm and an impending rupture due to a type iiia endoleak.The physician elected to explant the devices which were disposed of after the procedure.The patient's current condition is unknown.After the initial report, clinical assessment determined that there was evidence to reasonably suggest a left common iliac artery occlusion occurred that was not included in the event as reported.The left common iliac artery occlusion was seen on the 2021 computerized tomography (ct) scan and was unchanged and untreated on the 2022 ct scan.The occlusion was discovered during a review of the 2021 and 2022 ct scans.Additionally, it was determined that the type iiia endoleak included complete component separation.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; 8009832284
• MDR Report Key: 14104520
• Report Number: 2031527-2022-00084
• Device Sequence Number: 15009884
• Product Code: MIH
• UDI-Device Identifier: 00818009010094
• UDI-Public: (01)00818009010094(17)181117
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2018
• Device Model Number: BA22-70/I16-30
• Device Lot Number: 1297631004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELA SUPRARENAL, LOT# 1389168002.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male